A Study of LY900014 in Participants With Type 1 Diabetes (PRONTO-T1D)
Status and phase
Completed
Phase 3
Conditions
Type 1 Diabetes Mellitus
Treatments
Drug: Insulin Lispro
Drug: Insulin Degludec
Drug: Insulin Glargine
Drug: LY900014
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).
Enrollment
1,392 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
- HbA1c of ≥7.0 and ≤9.5%.
- Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.
- Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.
Exclusion criteria
- Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening.
- Have had more than 1 severe hypoglycemic episode within 6 months of screening.
- Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.
- Have clinically significant gastrointestinal disease.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
1,392 participants in 6 patient groups
LY900014
Experimental group
Description:
LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Treatment:
Drug: LY900014
Drug: Insulin Degludec
Drug: Insulin Glargine
Insulin Lispro (Humalog)
Active Comparator group
Description:
Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Treatment:
Drug: Insulin Degludec
Drug: Insulin Lispro
Drug: Insulin Glargine
LY900014 Postmeal (Open Label)
Experimental group
Description:
LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
Treatment:
Drug: LY900014
Drug: Insulin Degludec
Drug: Insulin Glargine
LY900014 - Maximum Extended Enrollment (MEE)
Experimental group
Description:
LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Treatment:
Drug: LY900014
Drug: Insulin Degludec
Drug: Insulin Glargine
Insulin Lispro (Humalog)-MEE
Active Comparator group
Description:
Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Treatment:
Drug: Insulin Degludec
Drug: Insulin Lispro
Drug: Insulin Glargine
LY900014 Postmeal (Open Label)-MEE
Experimental group
Description:
LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
Treatment:
Drug: LY900014
Drug: Insulin Degludec
Drug: Insulin Glargine
Trial contacts and locations
171
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Data sourced from clinicaltrials.gov
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